drugset / Trial / NCT00147316
Japan Alteplase Clinical Trial (J-ACT): Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Ischemic Stroke
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Based on previous studies comparing Duteplase\[a recombinant tissue plasminogen activator (rt-PA) very similar to alteplase\] doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese.
Timeline
- Start
- 2002-04
- Primary completion
- —
- Completion
- 2003-09
Outcome
Met primary endpoint
paper this proportion (36.9%) exceeded the predetermined threshold of 33.9%. PMID 16763187 ↗
paper this incidence (5.8%) was lower than the threshold of 9.6%. PMID 16763187 ↗
Publications
- Results Yamaguchi T, Mori E, Minematsu K, Nakagawara J, Hashi K, Saito I, Shinohara Y; Japan Alteplase Clinical Trial (J-ACT) Group. Alteplase at 0.6 mg/kg for acute ischemic stroke within 3 hours of onset: Japan Alteplase Clinical Trial (J-ACT). Stroke. 2006 Jul;37(7):1810-5. doi: 10.1161/01.STR.0000227191.01792.e3. Epub 2006 Jun 8.
- Hirano T, Sasaki M, Tomura N, Ito Y, Kobayashi S; Japan Alteplase Clinical Trial Group. Low Alberta stroke program early computed tomography score within 3 hours of onset predicts subsequent symptomatic intracranial hemorrhage in patients treated with 0.6 mg/kg Alteplase. J Stroke Cerebrovasc Dis. 2012 Nov;21(8):898-902. doi: 10.1016/j.jstrokecerebrovasdis.2011.05.018. Epub 2011 Jul 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alteplase | Protein / enzyme biologic | 0.6 mg/kg | Intravenous |